MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC ULTIMA ACTIVATOR II REUSABLE DRIVE MECH; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Model Number ULTIMA ACTIVATOR II REUSABLE DRIVE MECH

Device Problem Corroded (1131)

Patient Problem No Patient Involvement (2645)

Event Date 01/04/2021

Event Type  malfunction  

Manufacturer Narrative

Trackwise id (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure using ultima activator ii reusable drive mech,corrosion / rust formation in the treatment process by cssd.The device was not put into circulation by the employees of the cssd.No patient involvement.

Manufacturer Narrative

Updated sections: g4, g7, h2, h3, h6, h10.Corrected section: h8.Internal complaint number: (b)(4).The lot # 25134484 history record review was completed.There were ncmrs , rework, or deviations documented for the reported lot number.[16325-during qc dhr review of ua-5001 batch# 25134484, it was identified that the line clearance form mcv00009687 / p section 1 and section 2 were filled out incorrectly.Additionally, operation 0010 of the sfp is intended to record line clearance, however form mcv00009687 / p was used to perform line clearance.Therefore, operation 0010 should not be filled out.].Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure using ultima activator ii reusable drive mech, corrosion / rust formation in the treatment process by cssd.The device was not put into circulation by the employees of the cssd.No patient involvement.

• Brand Name: ULTIMA ACTIVATOR II REUSABLE DRIVE MECH
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 11237005
• MDR Text Key: 228948938
• Report Number: 2242352-2021-00083
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 00607567700901
• UDI-Public: 00607567700901
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ULTIMA ACTIVATOR II REUSABLE DRIVE MECH
• Device Catalogue Number: C-UA-5001
• Device Lot Number: 25134484
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 01/27/2021
• Supplement Dates Manufacturer Received: 02/24/2021
• Supplement Dates FDA Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1